The Food and Drug Administration (FDA) of the Philippines has issued an amendment to FDA Circular No. 2021-023 extending the current validity of market authorizations, Special Certification, for COVID-19 Test Kits, from 31 December 2021 to 31 January 2022. This extension is valid ONLY for COVID-19 Test Kits whose marketing
On 22 December 2021, the Health Sciences Authority (HSA) of Singapore published a medical device advisory alerting all industry stakeholders about a recent suite of cybersecurity vulnerabilities known as the Apache Log4j Vulnerabilities, that could potentially affect medical devices utilizing the Apache Java Logging Library Log4j. These cybersecurity vulnerabilities allow
The Philippines FDA issued Circular no. 2021-025 listing the latest guidelines for the application of FDA authorizations in light of the extended state of public health emergency. The extended state of emergency came into effect on 13 September 2021 by Proclamation no. 1218 and will last until 12 September 2022
On 9 December 2021, the Vietnam government released Decree No. 111/2021/ND-CP which amended Decree No. 43/2017/NĐ-CP on product labeling regulation, including medical devices. This decree will come into effect on 15 February 2022. According to this new decree, organizations and individuals producing, exporting, and importing goods must determine and label
New guidance on classifying products as medical devices has been issued by the Health Sciences Authority (HSA), Singapore. The publication of the final document entitled “Medical Devices Product Classification Guide” at the end of November 2021 follows a stakeholder consultation earlier in the year and incorporates additional clarifications on product
On 8 November 2021, the Vietnam government signed Decree 98/2021/ND-CP regulating the management of Medical Devices. The new decree enters into force on 01 January 2022. From this date, Decree 36/2016/NĐ-CP, Decree 169/2018/NĐ-CP, and Decree 03/2020/NĐ-CP will become obsolete. The new decree covers many aspects of medical device management from
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